Method for a central venous line catheter having a temperature control system

ABSTRACT

A kit of parts comprises a system and instructions for use for controlling patient temperature which uses a central venous line catheter having a heat exchange element. The central venous line catheter is provided with one or more lumens for providing access to the central blood supply of the patient, and with additional lumens for communicating heat exchange fluid to the heat exchange element. Heat exchange fluid temperature is controlled through a feed back loop in which patient temperature is sensed and used to control a temperature control unit comprising a heating device and/or a cooling device in heat exchange relationship with the heat exchange fluid. A tubing set transports the heat exchange fluid between the central venous line and the temperature control unit, with a pump serving to circulate the fluid in a closed fluid circuit in the system.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Continuation of pending prior application Ser. No.09/671,114 entitled Kit of Parts Including a Central Venous LineCatheter Having a Temperature Control System, filed on Sep. 28, 2000,which is a Continuation-in-part of U.S. patent application Ser. No.09/253,109 entitled Central Venous Line Catheter Having TemperatureControl System, filed Feb. 19, 1999, which is a Continuation-in-part ofU.S. patent application Ser. No. 09/063,984 entitled Indwelling HeatExchange Catheter and Method of Using Same, filed Apr. 21, 1998, nowissued as U.S. Pat. No. 6,126,684, the disclosures of which areincorporated herein by reference in their entirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The invention relates to catheters used for access to the central venousblood supply of a patient.

2. Description of Related Art

Catheters such as central venous line catheters are typically used inICU (intensive care unit) patients, particularly in those patients whohave suffered a stroke or other brain traumatic event. The centralvenous line catheters are typically about 8.5-12 French in size andconsist of a soft, flexible multi-lumen structure extending 8-12 inches.They are usually introduced through the subclavian or jugular vein, andless preferably in the femoral vein of the patient, serving to providethe caretaker with easy and convenient access to the patient's centralblood supply via the central venous system. In this manner generalaccess to the central blood supply is gained, enabling for exampledelivery of drugs, infusion fluids or nutrition, along with thegathering of patient blood for blood gas analysis and the like.

In many patients, such as ICU patients, fever is a common occurrence.Fever is particularly likely in neuro-ICU patients, and its onset canexacerbate detrimental effects in the brain. Conventional therapies tocontrol fever include treatment with acetaminophen (Tylenol), coolingblankets, ice water bladder lavages, and ice baths. All of theseapproaches to cooling a patient require excessive time to cool thepatient. Moreover, prior methods do not provide for precise control ofpatient cooling. As recognized herein, to optimize the advantage ofcooling a patient, it is important to cool the patient relativelyquickly in a controlled fashion.

Recognizing the above-mentioned deleterious effects of fever in ICUpatients and the insufficiencies of present temperature control methodsand devices, the present assignee has disclosed, in co-pending patentapplication Ser. Nos. 09/133,813 and 09/063,984, indwelling cathetersthat can be implanted in the body of a patient to remove heat from theblood supply of the patient. The indwelling catheters of theabove-referenced applications are disposed in a heat exchangerelationship with the blood supply, and a coolant is circulated throughthe catheters in a closed loop. These catheters lower the temperature ofbody tissue and, as mentioned above, can thereby improve the patient'smedical outcome.

As understood by the present invention, the advantages of theabove-referenced cooling catheters can be implemented into a centralvenous catheter configuration. As mentioned above, central venouscatheters are commonly used in many ICU patients, including neuro-ICUpatients, and with these combined recognitions, the present inventionunderstands that it would be advantageous to provide a central venouscatheter with the additional capability of cooling a patient. In doingso, the present invention satisfies the goals both of conventionalcentral venous catheters as well as providing a means for effectivelyand precisely managing patient temperature in a single device.

BRIEF SUMMARY OF THE INVENTION

The present invention overcomes the deficiencies of the prior art byproviding a kit of parts comprising a central venous line catheteradapted to actively exchange heat with the body of the patient tothereby raise or lower body temperature as required, along withinstructions for proper use of the central venous line catheter. Thecentral venous line catheter is provided with a heat exchange elementdisposed in heat exchange relationship with the blood of the patient.The heat exchange element houses a circulating fluid therein, with thefluid being automatically cooled or warmed exteriorly of the patient'sbody in accordance with a patient temperature feedback scheme.

By supplementing the known functions of a central venous line catheterwith the function of cooling or warming the patient's blood, the presentinvention takes advantage of existing access to the venous system and asingle incision, reducing the risk of additional complications. Theaccess, typically through the subclavian, jugular or femoral veins, isto the central blood supply, via the central venous system, and istherefore particularly expedient, permitting efficient cooling orwarming of patient body temperature. The term central venous systemgenerally relates to the portion of the venous system which returnsblood to the right heart, including the inferior and superior vena cava.A particular advantage of the invention is that the cooling function isperformed efficiently in tandem with a procedure which is known to belikely attended by fever, thus anticipating such fever and facilitatingits control. The heat exchange relationship between the system and thecentral venous system of the patient can be maintained for a prolongedduration—for example, from about one hour to about twenty-nine days.

The central venous line catheter in accordance with the inventioncomprises a tubular structure defining a plurality of lumens. At leasttwo of these lumens convey heat exchange fluid to a heat exchangeelement disposed at a distal, implantable end of the central venous linecatheter, while the rest of the lumens serve to provide access to thecentral blood supply of the patient. The heat exchange element is influid communication with a temperature control module via a tubing setwhich conveys the heat exchange fluid between the components. Thetemperature control unit, comprising a cooling and/or a heating device,operates in conjunction with a temperature controller to heat or coolthe heat exchange fluid depending on a sensed temperature of thepatient.

In a less preferred embodiment, the heat exchanger element of thepresent invention can be made of metal such as steel, and it can assumean appropriate configuration, such as an accordion-like configuration.

The system of the invention operates to maintain patient temperature ata desired level. Any deviation from the desired level automaticallytriggers corrective action, such as circulating the cooled heat exchangefluid through the central venous line catheter to contend with the onsetof fever. Additionally, the system is equipped with indicators whichsignal to the caretaker of the patient the sensed deviation, by forexample sensing the increased workload of the system, in order to warnof adverse physiological changes besetting the patient.

The invention thus provides a system for controlling patient temperatureusing a central venous line catheter having a heat exchange element. Thecentral venous line catheter is provided with one or more lumens forproviding access to the central blood supply of the patient, and withadditional lumens for communicating heat exchange fluid to the heatexchange element. Heat exchange fluid temperature is controlled througha feedback loop in which patient temperature is sensed and used tocontrol a temperature control unit comprising a heating device and/or acooling device in heat exchange relationship with the heat exchangefluid. A tubing set transports the heat exchange fluid between thecentral venous line and the temperature control unit, with a pumpserving to circulate the fluid in a closed fluid circuit in the system.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

Many advantages of the present invention will be apparent to thoseskilled in the art with a reading of this specification in conjunctionwith the attached drawings, wherein like reference numerals are appliedto like elements and wherein:

FIG. 1 is a schematic diagram showing a central venous line cathetertemperature control system in accordance with the present invention;

FIG. 2 is a schematic side elevational view of a central venous linecatheter in accordance with the invention;

FIG. 3 is a schematic cross-sectional view taken along line 3-3 of FIG.2;

FIG. 4 is a schematic cross-sectional view of a preferred arrangement ofa catheter in accordance with the invention;

FIG. 5 is a schematic sectional view of the distal portion of thecentral venous line catheter of the invention;

FIG. 6 is a schematic side elevational view of a central venous linecatheter in accordance with a second embodiment of the invention;

FIG. 7 is a schematic side elevational view of a central venous linecatheter in accordance with a third embodiment of the invention;

FIG. 8 is a perspective view of one embodiment of the present anchor;and

FIG. 9 is a perspective view of the kit of parts in accordance with theinvention.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 shows a temperature control system 10 in accordance with theinvention. A central venous line catheter 20 providing access to thecentral blood supply of the patient is disposed in heat exchangerelationship with the patient. Central venous line catheter 20 isprovided with a circulating heat exchange fluid (not shown) whosetemperature is automatically controlled in accordance with a feedbackscheme is order to achieve a desired patient target temperature ortemperature range. The feedback schemes involves sensing patienttemperature using a probe 54 whose output is provided to a temperaturecontroller 55 housed in a temperature control module 50. The temperaturecontroller 55 determines whether the sensed temperature represents adeviation from the desired temperature or range and selectivelyactivates a heat control unit 57 in order to heat or cool the heatexchange fluid depending on the direction of deviation. As described inmore detail below, the central venous line catheter 20 is a multi-lumendevice, with at least two of the lumens being dedicated to heat exchangefluid flow to and from a heat exchange element of the catheter. Theother lumen(s) can have different uses, such as fluid infusion or drugdelivery, or guidewire support, depending on the particular application.The preferred number of lumens is 3 to 5, although other numbers arecontemplated.

FIGS. 2-4 show in more detail the central venous line catheter 20, whichis a substantially elongate structure of generally cylindrical shapeadapted for insertion into the body of a patient, preferably into thesubclavian or jugular veins. Central venous line catheter 20 is formedof any known polymer material 23 defining its various lumens 32, 34, 42,44 and 46. A preferred material is polyurethane, although othermaterials, such as nylon, polyethylene and PEBAX, can also be used.Considerations in selecting the appropriate material 23 includebiocompatibility, flexibility, temperature change compatibility, andresistance to buckling.

At its distal, implantable end portion 22, catheter 20 is provided witha heat exchange element such as fluid-carrying inflatable balloon 24that is radially disposed around the width of the catheter. Balloon 24is disposed in the vicinity of flexible tip 21 and can be formed from apiece of sheet material 38 or extruded tubing formed into a moldedballoon of the desired shape and size and then bound or otherwise fixedto the shaft 25 to form a cavity 36. As illustrated, balloon 24 is shownto have a significantly larger diameter than shaft portion 25 of thecatheter. For example, it is contemplated that in some applications thediameter of the inflated balloon will be more than three times that ofshaft 25. In one preferred embodiment, the balloon diameter is fourmillimeters to ten millimeters (4 mm-10 mm). Preferably, the diameter ofthe balloon is selected to be no more than 40%-60% of the diameter of atypical vena cava. It is to be appreciated that in some cases it may bedesirable to maximize the dimension of the shaft 25 in order tofacilitate heat exchange fluid flow. This will also minimize the volumeof fluid in the balloon 24 and promote a more rapid heat exchange. Itwill be further appreciated that myriad balloon shapes can be utilizedwith the invention, including but not limited to spiral or flutedshapes, as disclosed in the aforementioned co-pending patentapplications. The particular shape selected would depend on theapplication and the desired heat exchange and other characteristics. Inone preferred embodiment, the balloon 24 is made of urethane, nylon, orPET and is thin-walled, i.e., the balloon 24 has a wall thickness ofless than three mils, and more preferably less than one and one-halfmils. Also, the balloon 24 preferably is coated with an antimicrobialsubstance, as well as an anticlot substance, such as heparin.

It is to be understood that the balloon 24 can extend the entire lengthof the portion of the central venous catheter that is intubated in thepatient. Typically, this length is about 15 cm. Under suchcircumstances, the diameter of the balloon need not be larger than thediameter of a conventional central venous catheter, e.g., the diameterof the balloon can be 12 French, 10 French, or even as small as 7.5French. More broadly, the balloon diameter, when the balloon extendsalong the entire length of the intubated portion of the catheter, can be5-13 French. In an arrangement where multiple balloons are used asdetailed below, these balloons can cover the entire length of theintubated portion of the catheter. That is, two balloons of about 7.5 cmeach can be used, or three 5 cm balloons, etc.

As can be seen more clearly with reference to FIGS. 3 and 4, a pair oflumens 32 and 34 are formed in catheter 20, with lumen 32 serving as aninflow channel supplying balloon 24 with heat exchange fluid which iscirculated through the catheter 20, while lumen 34 serves as an outflowchannel returning the heat exchange fluid from the balloon 24 to thecatheter. The particular heat exchange fluid selected is preferablybiocompatible to avoid harm to the patient in the event of inadvertentrupture. Candidate materials include sterile saline water and carbondioxide gas, although other fluids having suitable viscosity, heatexchange and material compatibility characteristics can also be used.While less desired because it is not biocompatible, freon canalternatively be used.

Balloon 24 is in fluid communication with lumens 32 and 34 via aplurality of ports such as inlet port 26 and outlet port 28. Heatexchange fluid circulated in catheter 20 passes from lumen 32 intocavity 36 through inlet port 26, then out of cavity 36 to lumen 34through outlet port 28. While in the cavity 36, the heat exchange fluid,which is remotely cooled outside the central venous line catheter 20,serves to provide a cold temperature fluid on the inner surface of thesheet material 38 which forms the walls of balloon 24. With a bodyfluid, such as blood, flowing exteriorly of the balloon 24, heattransfer occurs across the sheet material 38, effectively cooling thebody of the patient and countering the effects of a fever. To that end,inlet port 26 is positioned distally of outlet port 28.

Efficient heat transfer is also promoted by specific considerationsregarding the cross-sectional shape of the lumens 32 and 34.Specifically, as can be seen from FIG. 3, the lumens 32 and 34 aredesigned to maximize the volume of fluid flowing therethrough. This isaccomplished by providing the lumens with crescent cross-sectionalshapes so as to occupy circumferentially a maximum arc length in thecatheter 20. This volume maximization, however, may be at the expense ofthermal efficiency since the crescent cross-sectional shapes providegreater surface area for undesirable heat exchange with the exterior ofthe catheter 20 in the shaft portion 25. To obviate this, the preferredcross-sectional shape, shown in FIG. 4, more effectively isolates lumens32 and 34 from the exterior of catheter 20 by the structural material 37of the catheter.

In order to facilitate fluid flow in and out of cavity 36 of balloon 24,outlet port 28 can be made larger than inlet port 26 to reduce theresistance encountered by the heat exchange fluid as it exits theballoon 24. This relative size difference becomes particularly importantwhen multiple balloons are provided in catheter 20 as is contemplated inaccordance with an alternate embodiment of the invention. Specifically,although described in terms of a single balloon 24, it will beappreciated that several such balloons can be provided, disposed axiallyalong the length of shaft 25, as shown in FIG. 6. One advantage of amultiple balloon configuration is that the flow and temperature of theheat exchange fluid can be more easily controlled along the entirelength of the heat exchange region of the catheter 20. Realizing thatthe heat exchange fluid will be coolest prior to entering into heatexchange with the blood, and warmest after that heat exchange, one canadvantageously control not only the velocity and volume of flow, butalso the direction of flow within each of the balloons 24. Anotheradvantage of a multiple balloon design is the ability of the catheter tobend and flex when placed in a curved vasculature.

Catheter 20 is also provided with two or three lumens 42, 44 and 46 inaddition to lumens 32 and 34. Lumens 42, 44 and 46 can serve amultiplicity of functions, including infusion of drugs such aschemotherapy, fluids and nutrition, access to syringes for sampling, andaccommodation of various sensors, such as thermistors to monitor thepatient, thus generally providing access to the central blood supply asdictated by the particular application. Additionally, central lumen 44may be made of a different diameter than side lumens 42 and 46 in orderto better support a guidewire for instance. The lumens extendsubstantially the full length of catheter 20, from proximal end portion27 to distal end portion 22. The number of lumens provided can be varieddepending on the particular application.

It will also be appreciated that the heat exchange element does notnecessarily need to be in the form of a balloon such as balloon 24.Rather, arrangements such as an array of flexible hollow fibers throughwhich the heat exchange fluid is circulated can also be used, thusaffording greater surface area for heat exchange interaction. Such anarrangement, along with other heat exchange element arrangements whichcan be used with the invention, is disclosed in the afore-mentionedco-pending patent application Ser. No. 09/133,813, herein incorporatedby reference in its entirety. A hollow fiber heat exchange elementconfiguration is shown in FIG. 7. Hollow fibers 58 receive fluid frominner heat exchange fluid lumen 62 and return this fluid to outer heatexchange fluid lumen 64 of catheter 20. Additional lumens such as lumen66 are also provided to facilitate delivery of fluids and for otheruses. An important advantage of a hollow fiber heat exchange elementarrangement is that it enables communication between the inner lumens,such as lumen 66, and the blood anywhere along the length of the heatexchange element, via for example port 68.

With reference again to FIG. 1, and in cross-reference to FIG. 2, thecatheter 20 operates in conjunction with a temperature control module50. A tubing set 52 (FIG. 1) including coolant inlet and outlet fittings52 a, 52 b (FIG. 2) conveys fluid between temperature control module 50and catheter 20 in a closed fluid circuit through which the fluid iscirculated, using known pumping means (not shown) such as for example adiaphragm pump, bladder pump, piston pump, peristaltic pump, etc. It isto be understood that the inlet and outlet fittings 52 a, 52 b establishpathways of fluid communication from the temperature control unit 57 tothe lumens 32, 34, respectively of the catheter 20. A temperaturecontroller 55, which may be a microprocessor having appropriateinformation storage memory (not shown), is provided in temperaturecontrol module 50 and receives patient temperature signals from probe54. By controlling the input to a temperature control unit 57, which maybe a cooling device and/or a heating device in heat exchangerelationship with the cooling fluid, temperature controller 55automatically adjusts the temperature of the heat exchange fluidaccording to a desired target temperature or temperature range. Thetarget temperature or range can be entered using an input device such askeyboard 56. A display device such as LCD 58 displays various parametersto provide indications of system operation and/or patient condition.

Preferably, the target temperature is selected to be normal bodytemperature, and any deviation from this temperature, for exampleinduced by the onset of fever, is sensed by the probe 54 andautomatically corrected by the system of the invention. Temperaturecorrection is effected by for example activating temperature controlunit 57 of temperature control module 50. In cooling applications,temperature control unit 57 causes cooling of the circulating fluid andultimately the cooling of the patient's core body temperature, which ismonitored by probe 54. When normal temperature is achieved, thetemperature control unit 57 can then be automatically switched off orits cooling effect reduced by the temperature controller 55. Suitabletemperature control algorithms taking into account performanceparameters of system components and system time constants areimplemented by temperature controller 55 to effect accurate temperaturecontrol. For more expedient temperature control, module 50 may also beprovided with a heating device as part of the temperature control unit57, which heating device can also be automatically activated, usingfeedback from probe 54, to for example prevent overshooting the desiredtarget temperature or range, or even to induce hyperthermia in somesituations. It will be appreciated that probe 54 can be used to providetemperature feedback from any part of the patient's body, rectally forinstance, or it can provide temperature information anywhere in thefluid circuit, which information can then be correlated to the patient'score temperature using known parameters such as heat conductivity ofdifferent portions of the system and patient data such as weight,height, age, etc. Additionally, more than one probe can be used toprovide combinations of readings from the patient and/or from the systemto improve accuracy under some circumstances.

In accordance with the invention, the feedback scheme can be used tomaintain desired temperature conditions for a patient. Specifically, thesystem can be used to control any temperature deviations from anacceptable temperature range, which may be a normothermic range, wherebyprobe 54 will trigger cooling or heating of the patient's body dependingon this sensed deviation from the predetermined range. Moreover, sincethis deviation is generally indicative of certain physiological activityof which the patient's caretaker should be apprised, the operation ofthe system can be used as an indication that this physiological activityis taking place. For instance, when the cooling operation of temperaturecontrol unit 57 is activated due to a rise in the patient's core bodytemperature, the system cooling activity, as reflected in the increasedworkload of the cooling componentry of the system, is then used toindicate to the caretaker, audibly or visibly using an alarm or otherstatus indicator device (not shown) for instance, that the patient'sbody is attempting to enter a fever state. Appropriate measures can thenbe taken. Parameters other than workload can be used to provide thisindication, such as the slope of the temperature feedback along with thesign of the slope. Alternatively, a direct indication of patienttemperature as sensed by the probe 54 can be used. In this manner, useof the system for extended periods of time—for example, from about onehour to about twenty-nine or more days—is facilitated.

In cross-reference to FIGS. 1 and 2, in addition to being connected tothe temperature control unit 57, the central venous catheter 20 isconnected to one or more central venous components 70, 72 (only twovenous components shown in FIG. 1 for clarity of disclosure) viarespective fittings 74, 76, 78 as appropriate (FIG. 2) to establishcommunication between the central venous components 70, 72 and selectedlumens 42, 44, 46 of the catheter 20. As intended by the presentinvention, the central venous components 70, 72 can be established byone or more of: drug infusion sources, blood receptacles for receivingblood through the catheter 20, a guide wire, etc.

Additionally, as best seen in FIG. 2, the catheter 20 includes an anchorconfigured for affixing the catheter 20 to the patient. Morespecifically, in one intended embodiment, the anchor is established by asuture fitting 80. The suture fitting 80 can be made integrally with thecatheter 20, or it can be made as a separate plastic fitting andsurroundingly engaged with the catheter 20. As shown, the suture fitting80 includes two eyes 82, 84 through which sutures can be positioned andengaged with the patient's skin or with a bandage or tape or otherstructure that has been fastened to the patient. Alternatively, thepresent anchor can be established by a piece of tape 86, shown in FIG.8, that can tape the catheter of the present invention to the patient.Yet again, the present anchor can include another fastening device suchas a plate with adhesive surface that can be engaged with the patient,with the plate including structure configured for receiving the catheterof the present invention. As understood herein, an anchor is desirablein a central venous catheter to hold the catheter on the patient,because a central venous catheter typically is intended for prolongedindwelling.

FIG. 9 is a schematic view of a kit of parts containing a central venousline catheter 20 and instructions for use 90 of same in accordance withthe invention. The kit of parts includes a package 92, having a box anda cover. The box housing the catheter 20. The cover including aninterior. The instructions for use 90 mount on the interior of the coverand can be in the form of a booklet, or a card or label which may beadhered to the package 92 comprising the kit or otherwise associatedwith the central venous line catheter 20. The instructions for use 90would be product-specific, depending on the particular model, size andapplication, and would instruct the operator of the catheter 20 onproper use of the catheter, for example including a description of thespecifications of the catheter and the compatible equipment andmaterials with which its use is recommended. Warnings and precautionswould also be included, along with contraindications, preparationprocedures, and other medically important information. The followingrepresents an exemplary of a set of instructions for use in accordancewith the invention:

Device Description:

The COOL LINE™ Heat Exchange Catheter is a sterile, single use flexible8.5F catheter designed for placement in the central venous circulationfrom an insertion site in the jugular, subclavian, or femoral veins. TheCOOL LINE™ catheter is to be connected to an ALSIUS single usedisposable COOLGARD™ Tubing Set (supplied separately) and the COOLGARD™System. A dilator and guidewire are required for the percutaneousinsertion of the COOL LINE™ catheter. Two lumens are available forinfusion, measuring central venous pressure and sampling. Flow rates:Proximal port (blue) 1400 ml/hr. Distal Guidewire Port (brown) 2200ml/hr. The COOL LINE™ blood contact surfaces are Duraflo® treated.

Indications for Use:

The ALSIUS COOL LINE™ Catheter in combination with the COOLGARD™ Systemis for reducing fever in neurointensive care unite patients.

Safety and Efficacy Consideration:

Product designed for single use only. Do not resterilize or reuse. Donot reinsert, once removed from patient. Do not alter the catheter inany way. Central venous catheterization should only be performed bywell-trained personnel well versed in anatomical landmarks and safetechnique. Personnel should also have knowledge of potentialcomplications.

Warning: Do not allow catheter to be placed into right atrium or rightventricle. Placement in right atrium or right ventricle can result insevere patient injury or death.

Contraindications:

1. Bleeding diathesis.

2. Active sepsis.

3. Infection or active bleeding at the site of catheter insertion.

4. Patients with no vascular access.

Warnings and Precautions:

1. Catheter should be placed via a jugular, subclavian, or femoral veinapproach only.

2. Do not allow catheter to be placed into right atrium or rightventricle. If placed via the jugular or subclavian veins, cathetershould be positioned so that the distal tip of catheter is in thesuperior vena cava above its junction with the right atrium and parallelto the vessel wall. X-ray examination should be used to ensure that thecatheter is not in the right atrium or ventricle. The distal tip of thecatheter should be positioned at a level above either the azygos vein orthe carina of the trachea, whichever is better visualized.

3. If placed via the femoral vein, the catheter should be positioned sothat the distal tip of catheter is in the inferior vena cava below itsjunction with the right atrium and parallel to the vessel wall.

4. Possible complications with central venous catheters include: atrialor ventricular perforation, cardiac tamponade, air embolism, catheterembolism, thoracic duct laceration, bacteremia, septicemia, thrombosis,inadvertent arterial puncture, hematoma formation, hemorrhage, nervedamage and dysrhythmias.

5. All Luer-Lock connections and covers must be securely tightened toprevent air embolism or fluid or blood loss.

6. Never use excessive force in moving the catheter or guidewire. Ifresistance is encountered, an x-ray should be performed to identify thereason for the resistance.

7. Passage of the guidewire into the right heart can cause dysrhythmias,right bundle branch block, vessel wall, atrial or ventricularperforation.

8. Use only sterile normal saline for catheter priming and as thecirculating fluid in the catheter.

9. Catheter should be routinely inspected for flow rate, security ofdressing, correct catheter position and for secure Luer-Lock connection.Use centimeter markings to identify if the catheter position haschanged.

10. Only x-ray examination can ensure that the catheter tip has notentered the heart or no longer lies parallel to the vessel wall. Ifcatheter position has changed, perform an x-ray examination to confirmcatheter tip position.

11. For blood sampling, temporarily shut off remaining infusion portsthrough which solutions are being infused.

12. Alcohol and acetone can weaken the structure of the polyurethanematerial. Care should therefore be taken when infusing drugs containingalcohol or when using alcohol or acetone when performing routinecatheter care and maintenance. Alcohol should not be used to doctor thecatheter.

13. Use are when infusing drugs that may be affected by cooltemperatures (as low as 4° C.).

14. Use of a syringe smaller than 10 ml to irrigate or declot anoccluded catheter may cause intraluminal leakage or catheter rupture.

15. Do not infuse into the teal-green Luer-Lock connections.

16. Fever may have infectious and/or non-infectious causes in patients.Mitigation of fever as a sign of possible infection necessitates daily,meticulous assessment for other signs of infection.

More warnings and precautions are located in following instructions.

Materials Required:

Quantity Description 1 COOL LINE ™ Kit for percutaneous introduction 1Bag of Normal Saline (1000 ml) 1 COOL LINE ™ Catheter 1 COOLGARD ™Tubing Set 1 COOLGARD ™ System 1 Pack of Sterile Luer Caps (suppliedwith the COOLGARD ™ Tubing Set)

Catheter Preparation and Insertion:

Use sterile technique.

1. Caution: Use jugular, subclavian, or femoral vein approach only.

2. Place patient in a slight Trendelenburg position as tolerated toreduce the risk of air embolism. If femoral approach is used, placepatient in supine position.

3. Prep and drape puncture site as required.

4. Caution: Always prime catheter before it is inserted into patient.

5. Carefully remove catheter from package leaving on catheter membranecover.

Catheter Preparation Procedure:

1. Remove caps from the inflow and outflow luer hubs. With the cathetercover in place, fill syringe (5 cc or larger) with sterile saline andattach syringe to female inflow luer hub.

2. Warning; Never inject positive pressure into the inflow hub with theoutflow luer cap in place.

3. Gently inject saline through catheter until it begins to exit fromoutflow luer.

4. Using 5 cc or larger syringe, flush the distal and proximal infusionlumens with sterile saline. Clamp or attach injection caps to theproximal infusion lumen. Leave the distal luer uncapped for guidewirepassage.

5. Remove catheter membrane cover. Inspect catheter to assure that airhas been purged from the heat exchange membrane. Inspect the catheterfor leaks.

6. Warning: Do not cut the catheter to alter length.

Catheter Insertion:

1. Obtain jugular, subclavian, or femoral venous access using standardpercutaneous techniques. Access should be maintained with a 0.032″guidewire.

2. Caution: Do not use guidewire larger than 0.032″ with the COOL LINE™catheter.

3. Holding spring guidewire in place, remove introducer catheter.Precaution: Maintain a firm grip on the guidewire at all times.

4. Enlarge the cutaneous puncture site with cutting edge of scalpelpositioned away from the guidewire. Warning: Do not cut guidewire. Usevessel dilator to enlarge site as required. Do not leave vessel dilatorin place as an indwelling catheter to minimize risk of possible vesselwall perforation.

5. Thread tip of COOL LINE™ over guidewire. Maintain a sufficiently firmgrip on the guidewire during catheter insertion. Grasping near skin,advance catheter into vein with a slight twisting motion.

6. Using centimeter marks on the catheter as positioning referencepoints, advance catheter to final indwelling position.

7. Hold catheter at desired depth and remove guidewire. If resistance isencountered when attempting to remove the guidewire after catheterplacement, the guidewire may be kinked about the tip of the catheter. Ifresistance is encountered, withdraw the catheter relative to theguidewire about 2-3 cm and attempt to remove the guidewire. Ifresistance is again encountered remove the guidewire and cathetersimultaneously.

8. Caution: Do not apply undue force to the guidewire.

9. Verify that the guidewire in intact upon removal.

10. Check lumen placement by attaching a syringe to the distal andproximal infusion luer hubs and aspirate until a free flow of venousblood is observed. Connect infusion luers to appropriate Luer-Lockline(s) as required. Unused infusion port(s) may be “locked” through theinjection cap(s) using standard hospital protocol. Slide clamps areprovided on the tubing to occlude flow through the infusion lumensduring line and injection cap changes. Precaution: To minimize risk ofdamage to the tubing from excessive pressure, each clamp must be openedprior to infusing through that lumen.

11. Caution: Do not clamp or occlude inflow or outflow lines. This cancause line blockage and possible failure.

12. Secure and dress catheter temporarily.

13. If subclavian or jugular access is used, verify catheter tipposition by chest x-ray immediately after placement. X-ray exam mustshow the catheter located in the right side of the mediastinum in theSVC with the distal end of the catheter parallel to the vena cava wall.The catheter distal tip must be positioned at a level above either theazygos vein or the carina of the trachea, whichever is bettervisualized. If the catheter tip of malpositioned, reposition andreverify.

14. If femoral access is used, X-ray examination must show the catheterlocated in the IVC with the distal end of the catheter parallel to thevena cava wall. If the catheter tip is malpositioned, reposition andreverify.

15. Proximal radiopaque marker indicates proximal end of balloons toensure that balloons reside completely in vessel. If catheter ismalpositioned, reposition and reverify.

16. Secure catheter to patient. Use juncture hub side wings as primarysuture site.

17. The Alsius suture tab and clip can also be used as an additionalattachment point. Assure that catheter body is secure and does notslide.

18. Caution: Do not suture directly to the outside diameter of thecatheter to minimize the risk of cutting or damaging the catheter orimpeding catheter flow.

19. Maintain the insertion site with regular meticulous redressing,using aseptic technique.

20. Record on the patient's chart the indwelling catheter length usingthe centimeter marks on the catheter shaft as reference. Frequent visualreassessment should be made to ensure that the catheter has not moved.

21. Attach a primed Tubing Set to COOL LINE™ Heat Exchange Catheter byconnecting the male luer of the tubing set to the green female inflowluer of the COOL LINE™ catheter (labeled “inflow”) and the female luerof the tubing set to the green male outflow luer of the COOL LINE™catheter (labeled “outflow”). Assure that a sufficient amount of sterilesaline is present at the ends of the hubs to make an air freeconnection. Refer to COOLGARD™ manual for details on COOLGARD™operation.

22. Warning: Failure to connect the Tubing Set correctly to the cathetercould result in catheter failure. Do not attach the Tubing Set to thedark blue or brown luers.

23. Caution: Do not place any stopcocks in line that may beinadvertently shut off. This can cause line blockage and possiblefailure.

24. Pump saline through tubing set and catheter to assure that allconnections are secure and that there is no leaking. Allow any remainingair in system to be purged out.

25. Set COOLGARD™ pump to a setting of 210.

Disconnecting Catheter from COOLGARD™ System:

1. Stop circulation of saline through catheter.

2. Disconnect Tubing Set from catheter.

3. To maintain sterile connections, immediately cap off luer connectorsof both catheter and tubing set using sterile luer caps.

Reconnecting Catheter to COOLGARD™ System:

1. Remove luer caps from luer connectors of catheter and tubing set anddiscard.

2. Attach Tubing Set to COOL LINE™ Heat Exchange Catheter by connectingthe male luer of the Tubing Set to the female inflow luer of the COOLLINE™ catheter and the female luer of the Tubing Set to the male outflowluer of the COOL LINE™ catheter. Assure that a sufficient amount ofsterile saline is present at the ends of the hubs make an air freeconnection.

3. Warning: Failure to connect the tubing set correctly to the cathetercould result in catheter failure.

4. Caution: Do not place any extra stopcocks in line that may beinadvertently shut off. This can cause line blockage and possiblefailure.

Catheter Removal:

1. Stop all pumping of saline through the catheter.

2. Disconnect Tubing Set from catheter.

3. Place patient in supine position. Remove dressing. Remove suturesfrom suture site.

4. Slowly remove catheter from patient. As catheter exits the site applypressure with a dressing impermeable to air, e.g. vaseline gauze.

5. Warning: Do not move catheter if resistance is felt. If resistance isencountered, an x-ray should be performed to identify the reason for theresistance.

Sterility

Ethylene oxide sterilized. The COOL LINE™ Catheter is supplied sterilefor single use only and should not be resterilized. The package shouldbe inspected prior to use to ensure that the sterility barrier has notbeen compromised.

Storage

Store at room temperature, 15-40° C.

The above are exemplary modes of carrying out the invention and are notintended to be limiting. It will be apparent to one of ordinary skill inthe art that modifications thereto can be made without inventivedeparture from the spirit and scope of the invention as set forth in thefollowing claims.

1. A kit comprising: at least one box; at least one closure to removablycover an interior of the box; at least one closed loop heat exchangecatheter configured to exchange heat with blood when a heat exchangeportion of the catheter is disposed in the vasculature of a patient andworking fluid is circulated through the heat exchange portion;instructions for use of the catheter disposed in the interior betweenthe cover and the box.
 2. The kit of claim 1, wherein the instructionsare mounted on an interior side of the cover.
 3. The kit of claim 1,wherein the instructions are adhered to the cover.
 4. The kit of claim1, wherein the instructions are adhered to the box.